Title: Head of Clinical Development
Cellics Therapeutics is looking for an experienced Head of Clinical Development to provide strategic guidance and leadership for the design, planning, and execution of Cellics’ clinical development programs. The candidate will also work closely with other functional teams and collaborating research organizations. The ideal candidate will be a physician scientist with extensive drug development experience in infectious diseases and/or inflammatory/autoimmune diseases.
Essential Duties and Responsibilities:
The duties and responsibilities of the Head of Clinical Development include but are not limited to the following:
- Lead the design, planning, and execution of Cellics’ clinical development programs.
- Oversee clinical CROs and clinical team members to ensure that clinical trials are managed and executed in accordance with timelines and quality standards.
- Manage the clinical aspects of regulatory strategies and filings and interactions with regulatory agencies;
- Oversee the analysis and interpretation of clinical trial data and the reporting of clinical trial results.
- Lead interactions with key opinion leaders, clinicians, patient groups, and other clinical stakeholders.
- Provide strategic insights and evaluation to prioritize non-clinical programs to advance into clinical development and work closely with other functional teams to facilitate the development of these programs.
- Build, train, and manage the clinical development team.
- Give presentations to external audiences, including the investment, medical and regulatory communities, as well as pharmaceutical or biotechnology industry.
- Medical Doctor (M.D.), relevant medical training or drug development experience in infectious or inflammatory/autoimmune diseases preferred.
- Minimum 10 years of experience in pharmaceutical or biotechnology industry with a proven success record in the design and execution of clinical trials for therapeutic drugs.
- In-depth knowledge of clinical research concepts, Good Clinical Practice (GCP), and ICH guidelines.
- Knowledge of relevant regulations and guidelines of regulatory agencies and hands-on experience in regulatory filings such as IND and BLA and in interactions with FDA and other regulatory agencies.
- Solid understanding of the entire drug development process.
- Broad knowledge of the pharmaceutical and biotechnology industry and competitive landscape for infectious and inflammatory disease drugs.
- Demonstrated leadership and communication skills.
- Goal-driven, data-driven, and science-driven.
- A great team player who is able to build confidence and credibility internally and externally.
- Willing and able to be hands-on.
- Have the highest ethical standards and personal values.
If interested, please email a copy of your CV to firstname.lastname@example.org.